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Trial record 1 of 1 for:    Nintedanib Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)
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Nintedanib Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)

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ClinicalTrials.gov Identifier: NCT01979952
Recruitment Status : Completed
First Posted : November 8, 2013
Results First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Idiopathic Pulmonary Fibrosis
Interventions Drug: Matching Placebo
Drug: Nintedanib
Enrollment 113
Recruitment Details Patients were randomized to receive nintedanib or placebo in 1:1 ratio. After Global Amendment 1, study design was changed to exploratory, and duration of double blind, placebo-controlled part of study was reduced from 12 months to 6 months, followed by conversion of all patients to open-label nintedanib treatment for a duration of up to 18 months.
Pre-assignment Details  
Arm/Group Title Nintedanib Placebo
Hide Arm/Group Description Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months. Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
Period Title: Overall Study
Started 56 57
Completed 48 51
Not Completed 8 6
Reason Not Completed
Adverse Event             4             5
Protocol Violation             1             0
Withdrawal by Subject             2             1
Other than specified above             1             0
Arm/Group Title Nintedanib Placebo Total
Hide Arm/Group Description Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months. Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization Total of all reporting groups
Overall Number of Baseline Participants 56 57 113
Hide Baseline Analysis Population Description
Treated Set (TS) consisted of patients who were randomized to a treatment group and received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 57 participants 113 participants
68.8  (7.6) 66.2  (9.4) 67.5  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 57 participants 113 participants
Female
11
  19.6%
20
  35.1%
31
  27.4%
Male
45
  80.4%
37
  64.9%
82
  72.6%
1.Primary Outcome
Title Relative Change From Baseline in High Resolution Computerized Tomography (HRCT) Quantitative Lung Fibrosis (QLF) Score at 6 Months
Hide Description Relative change from baseline in HRCT QLF score at 6 months was calculated as the difference of the QLF score at month 6 minus the QLF score at baseline divided by the baseline QLF score. The QLF score itself ranges from 0 to 100%, where greater values represent a greater amount of lung fibrosis and are considered a worse health status. Hence smaller relative changes from baseline (i.e., ratios) were considered favorable. HCRT assessment obtained during screening visit was considered as baseline.
Time Frame Baseline and 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Observed Cases (6 months) (OC6): The OC6 consisted of all patients in the TS (all patients who were randomized to a treatment group and received at least 1 dose of study drug) with observed data for the primary endpoint (relative change from baseline in HRCT QLF score at 6 months).
Arm/Group Title Nintedanib Placebo
Hide Arm/Group Description:
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
Overall Number of Participants Analyzed 42 45
Least Squares Mean (Standard Error)
Unit of Measure: percent change
11.407  (4.4819) 14.583  (4.3297)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nintedanib, Placebo
Comments Analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline HRCT QLF score as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments As per the Clinical Trial Protocol, this is an exploratory trial hence p-values were not calculated.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 3.176
Confidence Interval (2-Sided) 95%
-9.227 to 15.579
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.2370
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Effect of Six Month Delayed Treatment Onset: Relative Change From Baseline in HRCT QLF Score at 12 Months
Hide Description

Relative change from baseline in HRCT QLF score at 12 months was calculated as the ratio of the QLF score at 12 months to baseline. Greater values of the QLF score represented a worse health status and hence smaller relative changes from baseline (i.e., ratios) were considered favorable.

HCRT assessment obtained during screening visit was considered as baseline. Note that due to the change in study design, patients randomized to the placebo group were treated with nintedanib after completion of the first 6-month treatment period. Therefore, this new endpoint was defined to address the effect of a 6-month delayed onset of nintedanib treatment.

Time Frame Baseline and 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Observed Cases (12 months) (OC12): The OC12 consisted of all patients in OC6 with observed QLF data at 12 months.
Arm/Group Title Nintedanib Placebo
Hide Arm/Group Description:
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
Overall Number of Participants Analyzed 30 31
Least Squares Mean (Standard Error)
Unit of Measure: percent change
13.103  (4.5454) 15.622  (4.4714)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nintedanib, Placebo
Comments Analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline HRCT QLF score as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments As per the Clinical Trial Protocol, this is an exploratory trial hence p-values were not calculated
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 2.519
Confidence Interval (2-Sided) 95%
-10.258 to 15.296
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.3829
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Absolute Change in Forced Vital Capacity (FVC) From Baseline at 6 Months
Hide Description Absolute change in Forced Vital Capacity (FVC) from baseline at 6 months is presented.
Time Frame Baseline and 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Treated Set (TS) (Only patients with observed cases (OC) values were analysed)
Arm/Group Title Nintedanib Placebo
Hide Arm/Group Description:
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
Overall Number of Participants Analyzed 54 54
Least Squares Mean (Standard Error)
Unit of Measure: milliliter (mL)
-14.18  (31.050) -83.18  (28.067)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nintedanib, Placebo
Comments Mixed Model for Repeated Measures (MMRM) model with fixed effects for treatment, visit, gender, age, height, treatment−by−visit, baseline FVC, baseline FVC−by−visit and random effect for patient. Within−patient errors are modelled by unstructured covariance matrix.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments As per the Clinical Trial Protocol, this is an exploratory trial hence p-values were not calculated.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 69.00
Confidence Interval (2-Sided) 95%
-8.74 to 146.75
Parameter Dispersion
Type: Standard Error of the Mean
Value: 39.182
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Relative Change in FVC From Baseline at 6 Months
Hide Description Relative change in FVC from baseline at 6 months is presented.
Time Frame Baseline and 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
TS (Only patients with observed cases (OC) values were analysed)
Arm/Group Title Nintedanib Placebo
Hide Arm/Group Description:
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
Overall Number of Participants Analyzed 54 54
Least Squares Mean (Standard Error)
Unit of Measure: percentage of change
-0.67  (1.05) -3.02  (0.95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nintedanib, Placebo
Comments MMRM model with fixed effects for treatment, visit, gender, age, height, treatment−by−visit, baseline FVC, baseline FVC−by−visit and random effect for patient. Within−patient errors are modelled by unstructured covariance matrix.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments As per the Clinical Trial Protocol, this is an exploratory trial hence p-values were not calculated.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 2.36
Confidence Interval (2-Sided) 95%
-0.29 to 5.00
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Categorical Change in FVC From Baseline at 6 Months
Hide Description Percentage of participants reporting categorical change in FVC from baseline at 6 months are presented.
Time Frame Baseline and 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
TS (Only patients with observed cases (OC) values were analysed)
Arm/Group Title Nintedanib Placebo
Hide Arm/Group Description:
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
Overall Number of Participants Analyzed 46 46
Measure Type: Number
Unit of Measure: Percentage of participants
Decrease >10% or 200 mL 6.5 23.9
Change within ≤10% AND ≤200 mL 76.1 71.7
Increase >10% or 200 mL 17.4 4.3
6.Secondary Outcome
Title St. George's Respiratory Questionnaire (SGRQ) Total Score Change From Baseline at 6 Months
Hide Description

SGRQ total score change from baseline at 6 months is presented. SGRQ is a health-related quality of life questionnaire divided into 3 components : symptoms, activity and impact.

The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status.

Means provided are the adjusted means based on all analyzed patients in the model (not only patients with a baseline and measurement at month 6).

Time Frame Baseline and 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
TS (Only patients with observed cases (OC) values were analysed)
Arm/Group Title Nintedanib Placebo
Hide Arm/Group Description:
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
Overall Number of Participants Analyzed 55 53
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-2.24  (1.682) -2.19  (1.699)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nintedanib, Placebo
Comments MMRM model included treatment, visit, baseline value, treatment-by-visit and baseline-by-visit as fixed effects and patient as random effect. Unstructured covariance was assumed for within patient variation
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-4.89 to 4.79
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.434
Estimation Comments [Not Specified]
7.Secondary Outcome
Title 6MWT Total Distance Walked Change From Baseline at 6 Months
Hide Description

Change in total distance covered in 6-minute walk test (6MWT) from baseline at 6 month is presented.

The 6-Minutes Walk Test (6-MWT) was conducted according to the American Thoracic Society (ATS) Criteria.

Time Frame Baseline and 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
TS (Only patients with observed cases (OC) values were analysed)
Arm/Group Title Nintedanib Placebo
Hide Arm/Group Description:
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
Overall Number of Participants Analyzed 55 52
Least Squares Mean (Standard Error)
Unit of Measure: meters
4.93  (11.415) -13.00  (11.476)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nintedanib, Placebo
Comments MMRM model included treatment, visit, baseline value, treatment-by-visit and baseline-by-visit as fixed effects and patient as random effect. Unstructured covariance was assumed for within patient variation
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 17.94
Confidence Interval (2-Sided) 95%
-14.21 to 50.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 16.190
Estimation Comments [Not Specified]
8.Secondary Outcome
Title University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) Change From Baseline at 6 Months
Hide Description

University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) change from baseline at 6 months is presented. Shortness of Breath Questionnaire measures the shortness of breath. It comprises of 24 items. Each item is scored on a scale between 0-5 where 5 represents maximal breathlessness. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome).

Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at month 6).

Time Frame Baseline and 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
TS (Only patients with observed cases (OC) values were analysed)
Arm/Group Title Nintedanib Placebo
Hide Arm/Group Description:
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
Overall Number of Participants Analyzed 53 50
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
3.42  (2.156) -1.46  (2.192)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nintedanib, Placebo
Comments MMRM model included treatment, visit, baseline value, treatment-by-visit and baseline-by-visit as fixed effects and patient as random effect. Unstructured covariance was assumed for within patient variation
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 4.89
Confidence Interval (2-Sided) 95%
-1.47 to 11.25
Estimation Comments [Not Specified]
9.Secondary Outcome
Title All-cause Mortality at 6 Months
Hide Description Percentage of subjects died from all causes between 0 to 6 months are presented.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Nintedanib Placebo
Hide Arm/Group Description:
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
Overall Number of Participants Analyzed 56 57
Measure Type: Number
Unit of Measure: Percentage of participants
0.0 5.3
10.Secondary Outcome
Title Respiratory Hospitalizations at 6 Months
Hide Description Percentage of subjects hospitalized due to respiratory problems between 0 to 6 months are presented.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Nintedanib Placebo
Hide Arm/Group Description:
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
Overall Number of Participants Analyzed 56 57
Measure Type: Number
Unit of Measure: Percentage of participants
0.0 7.0
11.Secondary Outcome
Title Respiratory Mortality at 6 Months
Hide Description Percentage of subjects who died due to respiratory cause between 0 to 6 months are presented.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Nintedanib Placebo
Hide Arm/Group Description:
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
Overall Number of Participants Analyzed 56 57
Measure Type: Number
Unit of Measure: Percentage of participants
0.0 3.5
12.Secondary Outcome
Title Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbations at 6 Months
Hide Description Percentage of subjects experienced first acute IPF exacerbations (based on Investigator reported adverse events) between 0 to 6 months are presented.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Nintedanib Placebo
Hide Arm/Group Description:
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
Overall Number of Participants Analyzed 56 57
Measure Type: Number
Unit of Measure: Percentage of participants
1.8 1.8
Time Frame From first drug administration till 28 days after end of treatment; up to 19 months
Adverse Event Reporting Description Treated Set
 
Arm/Group Title Nintedanib Placebo
Hide Arm/Group Description Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months. Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
All-Cause Mortality
Nintedanib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Nintedanib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   11/56 (19.64%)   14/57 (24.56%) 
Cardiac disorders     
Cardiogenic shock  1  1/56 (1.79%)  0/57 (0.00%) 
Myocardial infarction  1  1/56 (1.79%)  0/57 (0.00%) 
Eye disorders     
Glaucoma  1  0/56 (0.00%)  1/57 (1.75%) 
Gastrointestinal disorders     
Abdominal pain  1  0/56 (0.00%)  1/57 (1.75%) 
Intestinal infarction  1  1/56 (1.79%)  0/57 (0.00%) 
Infections and infestations     
Clostridium difficile infection  1  1/56 (1.79%)  0/57 (0.00%) 
Influenza  1  1/56 (1.79%)  0/57 (0.00%) 
Lyme disease  1  1/56 (1.79%)  0/57 (0.00%) 
Pneumonia  1  0/56 (0.00%)  2/57 (3.51%) 
Sepsis  1  1/56 (1.79%)  0/57 (0.00%) 
Injury, poisoning and procedural complications     
Vascular graft complication  1  1/56 (1.79%)  0/57 (0.00%) 
Investigations     
Liver function test increased  1  1/56 (1.79%)  0/57 (0.00%) 
Metabolism and nutrition disorders     
Hypocalcaemia  1  1/56 (1.79%)  0/57 (0.00%) 
Hypokalaemia  1  1/56 (1.79%)  0/57 (0.00%) 
Hyponatraemia  1  1/56 (1.79%)  0/57 (0.00%) 
Musculoskeletal and connective tissue disorders     
Flank pain  1  0/56 (0.00%)  1/57 (1.75%) 
Musculoskeletal pain  1  0/56 (0.00%)  1/57 (1.75%) 
Osteoarthritis  1  0/56 (0.00%)  1/57 (1.75%) 
Polymyalgia rheumatica  1  1/56 (1.79%)  0/57 (0.00%) 
Spinal column stenosis  1  1/56 (1.79%)  0/57 (0.00%) 
Spinal osteoarthritis  1  1/56 (1.79%)  0/57 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma  1  1/56 (1.79%)  0/57 (0.00%) 
Benign neoplasm of adrenal gland  1  1/56 (1.79%)  0/57 (0.00%) 
Breast cancer  1  0/56 (0.00%)  1/57 (1.75%) 
Metastatic malignant melanoma  1  0/56 (0.00%)  1/57 (1.75%) 
Squamous cell carcinoma  1  1/56 (1.79%)  0/57 (0.00%) 
Nervous system disorders     
Ataxia  1  1/56 (1.79%)  0/57 (0.00%) 
Transient ischaemic attack  1  0/56 (0.00%)  1/57 (1.75%) 
Psychiatric disorders     
Completed suicide  1  0/56 (0.00%)  1/57 (1.75%) 
Delirium  1  0/56 (0.00%)  1/57 (1.75%) 
Renal and urinary disorders     
Ureterolithiasis  1  0/56 (0.00%)  1/57 (1.75%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  1/56 (1.79%)  0/57 (0.00%) 
Haemoptysis  1  0/56 (0.00%)  1/57 (1.75%) 
Hypoxia  1  1/56 (1.79%)  0/57 (0.00%) 
Idiopathic pulmonary fibrosis  1  1/56 (1.79%)  3/57 (5.26%) 
Pleural effusion  1  0/56 (0.00%)  1/57 (1.75%) 
Pneumothorax  1  0/56 (0.00%)  1/57 (1.75%) 
Pulmonary hypertension  1  1/56 (1.79%)  0/57 (0.00%) 
Pulmonary oedema  1  1/56 (1.79%)  0/57 (0.00%) 
Respiratory failure  1  2/56 (3.57%)  1/57 (1.75%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nintedanib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   54/56 (96.43%)   51/57 (89.47%) 
Blood and lymphatic system disorders     
Eosinophilia  1  1/56 (1.79%)  3/57 (5.26%) 
Gastrointestinal disorders     
Abdominal pain  1  3/56 (5.36%)  5/57 (8.77%) 
Abdominal pain upper  1  3/56 (5.36%)  3/57 (5.26%) 
Constipation  1  2/56 (3.57%)  4/57 (7.02%) 
Diarrhoea  1  43/56 (76.79%)  40/57 (70.18%) 
Flatulence  1  0/56 (0.00%)  4/57 (7.02%) 
Gastrooesophageal reflux disease  1  5/56 (8.93%)  2/57 (3.51%) 
Nausea  1  16/56 (28.57%)  20/57 (35.09%) 
Vomiting  1  10/56 (17.86%)  9/57 (15.79%) 
General disorders     
Asthenia  1  0/56 (0.00%)  3/57 (5.26%) 
Fatigue  1  11/56 (19.64%)  9/57 (15.79%) 
Infections and infestations     
Bronchitis  1  4/56 (7.14%)  7/57 (12.28%) 
Influenza  1  8/56 (14.29%)  6/57 (10.53%) 
Lower respiratory tract infection  1  3/56 (5.36%)  0/57 (0.00%) 
Nasopharyngitis  1  5/56 (8.93%)  9/57 (15.79%) 
Respiratory tract infection  1  4/56 (7.14%)  3/57 (5.26%) 
Sinusitis  1  3/56 (5.36%)  3/57 (5.26%) 
Tooth abscess  1  3/56 (5.36%)  1/57 (1.75%) 
Upper respiratory tract infection  1  4/56 (7.14%)  7/57 (12.28%) 
Urinary tract infection  1  3/56 (5.36%)  5/57 (8.77%) 
Injury, poisoning and procedural complications     
Fall  1  1/56 (1.79%)  4/57 (7.02%) 
Investigations     
Alanine aminotransferase increased  1  3/56 (5.36%)  4/57 (7.02%) 
Aspartate aminotransferase increased  1  1/56 (1.79%)  3/57 (5.26%) 
Eosinophil count increased  1  4/56 (7.14%)  3/57 (5.26%) 
Gamma-glutamyltransferase increased  1  1/56 (1.79%)  3/57 (5.26%) 
International normalised ratio increased  1  3/56 (5.36%)  1/57 (1.75%) 
Prothrombin time prolonged  1  3/56 (5.36%)  1/57 (1.75%) 
Weight decreased  1  13/56 (23.21%)  4/57 (7.02%) 
Metabolism and nutrition disorders     
Decreased appetite  1  12/56 (21.43%)  6/57 (10.53%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/56 (3.57%)  5/57 (8.77%) 
Back pain  1  2/56 (3.57%)  3/57 (5.26%) 
Muscle spasms  1  1/56 (1.79%)  3/57 (5.26%) 
Musculoskeletal pain  1  3/56 (5.36%)  3/57 (5.26%) 
Pain in extremity  1  0/56 (0.00%)  4/57 (7.02%) 
Nervous system disorders     
Dizziness  1  5/56 (8.93%)  4/57 (7.02%) 
Headache  1  7/56 (12.50%)  9/57 (15.79%) 
Psychiatric disorders     
Depression  1  2/56 (3.57%)  3/57 (5.26%) 
Renal and urinary disorders     
Nephrolithiasis  1  1/56 (1.79%)  3/57 (5.26%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  9/56 (16.07%)  15/57 (26.32%) 
Dyspnoea  1  8/56 (14.29%)  9/57 (15.79%) 
Idiopathic pulmonary fibrosis  1  5/56 (8.93%)  4/57 (7.02%) 
Oropharyngeal pain  1  3/56 (5.36%)  1/57 (1.75%) 
Sleep apnoea syndrome  1  0/56 (0.00%)  3/57 (5.26%) 
Skin and subcutaneous tissue disorders     
Rash  1  3/56 (5.36%)  4/57 (7.02%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.1
This study was an exploratory trial that was not statistically powered to demonstrate significant differences between treatment groups for the efficacy endpoints evaluated.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01979952     History of Changes
Other Study ID Numbers: 1199.187
First Submitted: November 4, 2013
First Posted: November 8, 2013
Results First Submitted: December 14, 2017
Results First Posted: April 17, 2018
Last Update Posted: April 17, 2018